Quality control in clinical laboratory

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Total Quality management, Quality control, quality systems, Quality assessment and Quality assurrance

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Quality control in clinical laboratory

  1. 1. “ QUALITY CONTROL IN CLINICAL LABORATORY ” Moderator : Prof.Th.I.Devi Speaker : Dr.Gomi Basar Date & Time : 13th September 2013 @ 10.30 am Department of Biochemistry, RIMS, Imphal
  2. 2. Overview • Definition of Quality • Introduction to Quality Control • Fundamentals of Quality Management • Total Quality Management • Quality System And Assessment • Quality Control & Implementations • External Quality Control • New Quality Initiatives 2
  3. 3. Quality ?  sum-total of all the characteristics of a product/service that has a bearing upon the utilization of the product/service to the entire satisfaction of the consumer Conformance to the requirements of users or customers and the satisfaction of their needs and expectations  1) Acceptable  2) Accessible  3) Affordable  4) Appropriate3
  4. 4. Quality is.... • invisible whenGOOD • impossible to ignore when BAD 4
  5. 5. Introduction • The issue of laboratory quality has evolved over more than 4 decades since the 1st recommendation for quality control were published in 1965 • Now, quality control is seen as only one part of a total laboratory control program • Quality also includes: a) Total Quality Management (TQM)→ an activity to improve pt. care by having the lab monitor, its work to detect deficiencies & subsequently correct them 5
  6. 6. b) Continuous Quality Improvement (CQI) or Performance Improvement (PI)→ to improve the pt. care by placing the emphasis on not to make mistakes in the first place c) Quality Assurance (QA)→ external activities that ensure positive pt. outcomes. It measures what a lab can do to improve reliability 6
  7. 7. Fundamentals of Quality Management Principles of Quality management, assurance, and control have become the foundation by which clinical laboratories are managed and operated • Total Quality Management of clinical Laboratory • Control of pre-analytical variables • Control of analytical variables • External quality assessment & Proficiency testing programs 7
  8. 8. Total Quality Management • TQM also referred to as : total quality control (QC), total quality leadership, continuous quality improvement, quality management science or industrial quality management • Quality systems in healthcare organization is evolving • Public & Private pressure to contain costs are now accompanied by pressure for quality improvement (QI) • TQM provides – management philosophy for organizational development & a management process for improvement of quality in all aspects of work 8
  9. 9. • The Universal principles of TQM are (1) Customer focus (2) Management commitment (3) Training (4) Process capability & control (5) Measurement using quality-improvement tools • Costs must be understood in the context of quality • Quality = conformance to requirements • “Quality costs” Concepts of TQM 9 =“Costs of conformance” + “Costs of non conformance”
  10. 10. Quality Costs Costs of Conformance Costs of Nonconformance Prevention Costs Appraisal Costs External failure Costs Internal failure Costs Examples: Training Calibration Maintenance Examples: Inspection Quality control Examples: Scrap Rework Repeat runs Examples: Complaints Service Repeat request Understanding of quality & cost leads to a new perspective of relationship b/n these two concepts: “ Improvement in quality lead to reduction in costs” 10
  11. 11. Methodology • Quality improvement occurs when problems are eliminated permanently • Quality problems are primarily management problems because only management has the power to change work process • TQM views the organization as a support structure rather than a command structure • Most immediate processes required for the delivery of services are those of the frontline employees • Senior management’s role is to support the frontline employees & empower them 11
  12. 12. 12
  13. 13. • QLPs - include analytical processes & the general policies , practices, and procedures that define how all aspects of the work are done • QC- emphasizes statistical control procedures, but also includes nonstatistical check procedures • QA- concerned primarily with broader measures & monitors of lab performance (turnaround time, specimen identification, patient identification, test utility) • QI- a structured problem solving process to help identify the root cause of a problem & a remedy for that problem • QP- provides the planning steps Implementing TQM 13
  14. 14. These five components, which work together in a feedback loop, illustrate how continuous QI is accomplished and quality assurance is built into laboratory process 14
  15. 15. “Five –Q” framework also defines how quality is managed objectively with the “scientific method”, or the PDCA cycle QP-provides the planning step, QLP- establishes standard processes, QC & QA provide measures for checks and QI provides a mechanism through which to act on those measures 15
  16. 16. • TQM is also considered as a quality system that is implemented to ensure quality • QS- “ set of key quality elements that must be in place for an organization’s work operations to function in a manner to meet the organization’s stated quality objectives” 16
  17. 17. Quality Systems  The main objective of a laboratory is to provide reliable, timely and accurate test results. This is only possible through  consistent monitoring and evaluation of the laboratory’s performance  the implementation and follow-up of corrective actions for non-conformance to procedure 17
  18. 18. Quality Systems • A reputation based on 10,000 good quality results is damaged by 1 poor quality result • The establishment of robust testing systems is essential to the success of laboratory services and the treatment program • The establishment and continuous monitoring of quality systems in each testing laboratory is required for reliable and robust testing 18
  19. 19. Quality Systems • Provide the assurance of the quality of the test results • Ensure that the lab operations are coordinated, organised and standardised • Are tools to monitor performance 19
  20. 20. • QUALITY ASSESSMENT (EXTR.) QUALITY: A DEGREE OF EXCELLENCE • QUALITY CONTROL (INTER.) + QUALITY ASSURANCE 20
  21. 21. Quality Procedures • Internal Quality Control (IQC) – includes personnel, instrumentation, document control, reagent control and corrective action • External Quality Assurance (EQA) – External quality control is important to ensure the laboratory is performing to an external standard 21
  22. 22. Assessment of Quality System • Audit, On-site inspection • Internal • External • Accréditation Man-driven Material-driven • Quality Assessment • Internal • External • Schematic way: External Quality Assessment Scheme (EQAS) 22
  23. 23. QC v/s QA • Quality Control -QC refers to operational techniques that must be included during each assay run to verify that the requirements for Quality are met with • Quality Assurance - QA refers to all those planned and systematic activities to provide confidence that the results given out by the laboratory are correct The aim of QC is simply to ensure that the results generated by the test are correct. However quality assurance is concerned with much more: that the right test is carried out on the right specimen and that the right result and right interpretation is delivered to the right person at the right time 23
  24. 24. QUALITY ASSURANCE (QA) • The purpose of QA is the maintenance of the overall quality of patient results • All factors that effect the test results from the time the test Pre-analytic Analytic Post-analytic Specimen collection Specimen transport Specimen quality Result accuracy Clerical errors Analytical errors Assay repeat rates Result reporting Record keeping for patient and QC 24
  25. 25. The Quality Assurance Cycle •Data and Lab Management •Safety •Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Record Keeping Reporting Personnel Competency Test EvaluationsTesting 25
  26. 26. Quality Control & Implementation
  27. 27. Quality control • Quality control is a vital part of quality assurance – All labs benefit from quality control in terms of confidence in and reproducibility of test results • Recording and monitoring test variables such as temperature, reagents, controls and equipment function allows one to look objectively and retrospectively at parameters vital to the accuracy and precision of the test • Documentation allows one to foresee a potential problem before the situation requires corrective action and adversely effects patient results 27
  28. 28. Quality in labs is mutual responsibility of….. • Laboratory specialists • Clinicians • Public health physicians 28
  29. 29. Objectives of quality in lab • Support provision of high quality health-care – Reduce morbidity – Reduce mortality – Reduce economic loss • Ensure credibility of lab • Generate confidence in lab results 29
  30. 30. Consequences of poor quality • Inappropriate action – Over-investigation – Over-treatment – Mistreatment • Inappropriate inaction – Lack of investigation – No treatment • Delayed action • Loss of credibility of laboratory • Legal action 30
  31. 31. How to implement a QC program? – Establish written policies and procedures – Assign responsibility for monitoring and reviewing – Train staff – Obtain control materials – Collect data – Set target values (mean, SD) – Establish control charts, Eg- Levey-Jennings charts – Routinely plot control data – Establish and implement troubleshooting and corrective action protocols – Establish and maintain system for documentation
  32. 32. Hurdles in Quality Control • Accurate & timely test report are the responsibility of the laboratory • Total testing process must be managed properly in the preanalytical, analytical, and postanalytical places 32
  33. 33. Control of Preanalytical Variables Preanalytical variability is defined as errors which occur when non-analytical factors change the conc. of analytes • Test conducted- appropriate test should be requested & performed • Patient identification- labeling of specimen may be improper; corrected by bar coding • Turnaround time (TAT)-should be kept minimum • Laboratory logs- entry of patient & test details in lab registers & computers • Transcription errors- a substantial risk of transcription error exists from manual entry of data, even when results are double checked; computerization reduces this error 33
  34. 34. • Patient preparation- proper patient preparation is essential to obtain meaningful test result • Specimen collection- container, anticoagulant, time taken to send specimen to lab, corrected by using vacutainer tubes & collection of samples by lab personnel • Specimen Transport- critical for some tests • Specimen Separation, aliquoting- monitoring of the performance of the centrifuge, container used for storage • Personnel- variation fr person to person. Safety precautions for all specimens. Throughput time to be monitored on a weekly or monthly basis Control of Preanalytical Variables 34
  35. 35. Factors influencing analytical variables EQUIPMENT RELIABILITY: Meet technical needs, Compatible, User & maintenance friendly, Cost effective, Validated Procedural reliability using Standard Operating Procedures REAGENTS STABILITY, INTEGRITY AND EFFICIENCY: Stable, Efficient, Desired quality, Continuously available, Validated SPECIFICITY & SENSITIVITY OF SELECTED TEST: Adequate ST, Sufficient SP, cost effective, compatible with, available infrastructure and expertise, interpretable, meet s the needs/ objectives, validated PROFICIENCY OF PERSONNEL: Education, Training, Aptitude, Com petence, Commitment, Adequate number, CME, Supervision, Motivati on USE OF APPROPRIATE CONTROLS: • Internal: Labs, Calibrated against national • External: Supplied by manufacturer, National, Internation al DOCUMENTATION: All the written policies, plans, procedures, instructions and records, quality control procedures and recorded test results involved in providing a service or the manufacture of a product Assessment ANALYTICAL FACTORS 35
  36. 36. • Analytical variables must be controlled carefully to ensure accurate measurements by analytical methods • Reliable analytical methods are obtained through careful process of : (1) Selection (2) Evaluation (3) Implementation (4) Maintenance (5) Control • Clear concepts in relation to Analytical methods- Calibration, trueness, accuracy, precision, linearity, & limit of detection Control of Analytical Variables 36
  37. 37. Calibration • The calibration function is the relation between instrument signal(y) and conc. of analyte (x) y=f(x) or, x=f1(y) • It is set of operations that establish the relationship between values of quantities indicated by the instrument and the corresponding values realized by ”measurement standards” • Calibration function may be linear or curved graphically • In automated clinical chemistry instruments , the relation b/n analyte conc. and signal is often very stable • In traditional chromatography (HPLC), it is customary to calibrate each analytical run 37
  38. 38. Trueness • Trueness of measurements- closeness of agreement b/n the average value obtained from a large series of results of measurements and a true value • True value- The known, accepted value of a quantifiable property • Bias- The difference b/n average value & the true value • Measured value- Result of an individual’s measurement of a quantifiable property 38
  39. 39. Accuracy • Accuracy- the closeness of the agreement b/n the result of a measurement & a true conc. of the analyte 39
  40. 40. Precision • Precision- closeness of agreement b/n independent results of measurements obtained under stipulated conditions • It is the dispersion of replicate measurements • Inter-assay with multiple runs • Intra-assay: within a run 40
  41. 41. Precision • Repeatability (within same run) • Reproducibility or closeness of results to each other performed under changed conditions of measurement (time,operator,calibrators, reagent lots) – Measured by the standard deviation or coefficient of variation • Std. dev (σ)/mean(X) x 100 = % C.V. 41
  42. 42. Reliability • The ability to maintain both precision and accuracy 42
  43. 43. Linearity • Linearity refers to the relationship between measured & expected values over the analytical measurement range • May be considered in relation to actual or relative analyte concentration • Evaluated by plotting measured& expected conc., F- test, regression analysis of test run • Testing of linearity is related to assessment of trueness over the analytical measurement range • The presence of linearity is a prerequisite for a high degree of trueness 43
  44. 44. Limit of Detection & Quantification • Limit of blank (LoB): highest measurement result that is likely to be observed for a blank sample • Limit of Detection (LoD): lowest concentration of measurand that can be consistently detected in ≥ 95% of samples tested under routine laboratory conditions and in a given sample matrix • Limit of Quantification (LoQ): lowest actual amount of analyte that can be reliably detected and at which the total error meets the laboratory’s requirements for accuracy The distinction b/n different results interpretations is dependent on the relationship b/n LoQ, LoD and LoB “detected” “detected but below LoQ” “not detected” 44
  45. 45. Variables that may cause imprecision • Equipment – Multiple instruments – Pipettes – check precision – Sporadic maintenance • Reagents – Different Lots of Reagents lot-to-lot evaluation • Staff – Difference in training, competencies 45
  46. 46. Laboratory Equipment • All equipment in the laboratory – Should have instruction manuals regarding proper use and maintenance requirements – Should be monitored and recorded for quality control procedures, function checks, preventative maintenance and repairs • These should be documented and filed in separate log books →46
  47. 47. Laboratory Equipment • Before putting new equipment or a new method into service – it must be validated - This is accomplishment by correlation and/or agreement studies - The new method or equipment is validated against old method and/or equipment • Refrigerators and freezers - Record serial numbers - Record temperatures daily Maintaining correct temperatures is vital to maintaining the integrity of reagents and should be maintained as per manufacturers’ instructions. 47
  48. 48. Instrument Maintenance • CONTROLS and CALIBRATORS Manufacturers can provide calibrators and internal controls • REGULAR MAINTENANCE – Daily and weekly instrument maintenance – Monthly, six-monthly and annual maintenance as recommended by supplier • ROUTINE MAINTENANCE Ensure that instruments are serviced regularly by a specialised service engineer and that this maintenance is documented 48
  49. 49. Instrument Maintenance Required for: •Producing reliable test results •Minimizing instrument breakdown •Lowering repair costs •Preventing delays in reporting test results •Maintaining productivity •Lengthening instrument life 49
  50. 50. PIPETTE’S IMPACT ON QC •Pipette accuracy and precision must checked regularly - the first time of use and periodically thereafter •If either fails, it is important to follow the manufacturer’s instructions for repair and calibration • Improperly calibrated pipettes will affect our assay and should be checked for precision and accuracy bi-annually 50
  51. 51. PIPETTE’S IMPACT ON QC • Pipettes not passing accuracy checks should be cleaned and checked for worn parts, and be sent to and serviced by reliable vendors • Maintain complete records of pipette calibration function check – Include serial and other identifying numbers of each pipette 51
  52. 52. Reagents in Laboratory • How to store reagents – Always store according to the manufacturer’s recommendations – Reagents must be dated and initialed upon receipt – Lot numbers must be recorded in a reagent quality control record book – After preparation and/or when placed in service, reagents must be labeled when put “in service” according to the manufacturer’s suggested recommendations →52
  53. 53. • Reagent parallel testing – New reagent lots must be checked with old lots using a normal control before use – The variability for new lots of reagents compared to the current lot should not be greater than the variability found for triplicate samples of the current lot – Variability should be within 5% – Results of reagent checks must be recorded, dated and initialed – Document all lot to lot procedures with date and variability results Reagents in Laboratory 53
  54. 54. • Restrict all testing procedures to staff with appropriate technical training – Testing theory – Instruments – Testing procedures • Perform and document periodic performance assessments on all testing staff PERSONNEL (Staff) 54
  55. 55. PERSONNEL (Staff)  Active participation by everyone working in the system is required to meet quality standards & continuously improve performance  It is laboratory director's responsibility to employ sufficient qualified personnel for the volume and complexity of the work performed  Continuing education program should be provided  All documentation should maintained in personnel file  Regular meeting to keep staff informed of changes & to solicit their suggestion for improving the lab. service 55
  56. 56. Documentation • If you have not documented it, you have NOT done it … • If you have not documented, it is a RUMOUR !!! 56
  57. 57. Value of Documentation • Ensures processes and outcomes are traceable • Processes can be audited, thus external assessments can take place • Tool for training • Reminds what to do next 57
  58. 58. Key Documents • Results archive – File results in an organised and easily accessible manner • Laboratory monitoring – Documentation of temperature monitoring, reagent control, accuracy/precision assays, corrective actions, audit reports • Instrumentation – SOPs – Equipment files + Manuals – Service history records of the instrument – Records of daily, weekly and monthly calibrations and maintenance 58
  59. 59. Standard Operating Procedures (SOP) • comprehensively written document that describes the laboratory procedure and all other related issues • Essential for ensuring uniformity in laboratory procedures SOP for TFT •The SOP should define test performance, tolerance limits, reagent preparation, required quality control, result reporting and references 59
  60. 60. • The SOPM should be written in CLSI format and must be reviewed and signed annually by the Laboratory director • Must contain all test methods performed by the laboratory • The SOPM should be available in the work area. It is the definitive laboratory reference and is used often for questions relating to individual test • Any obsolete procedures should be dated when removed from SOPM and retained for at least 2 years 60
  61. 61. Outline for a CLSI Procedure Document A. Title: intent of the document; concise B. Purpose or Principle: “the process describes..” info. regarding theory, clinical implications of examination C. Procedure instruction: “how to do” a particular steps, steps involved D. Related Documents: listing of other procedures used E. References: reference the source of information F. Appendixes or attachments: additional information G. Author(s): author of the document should be documented H. Approved Signature: Evidence that the document has been approved 61
  62. 62. Validation  is about determining whether something does what it is supposed to do 62
  63. 63. Importance of validation • Validation - before we introduce something • Re-validation – after we have changed/modified – periodic • Validation is applied to: – SOP – reagents – equipment – software 63
  64. 64. Factors influencing quality: Post-analytical • Right recording and reporting • Right interpretation – Range of normal values • Right turnaround time • Report to right user 64
  65. 65. Reporting results • Proper procedure includes: – All data entry results should be verified by a section head or supervisor (when available) and reviewed by management for final interpretation and release of results – In the event that a report has already been sent out and needs correction, a new report is issued with updated report written on it • The old report remains in the patient file – Verbal result reports should be documented, listing the time of the receipt of the report 65
  66. 66. Housekeeping • Surface decontamination of instruments, benchtops, biosafety hoods and general tidiness • Disposal of biohazardous waste • Monitoring of fridge, freezer and incubator temperatures 66
  67. 67. Statistical Control of Analytical Methods • Statistics definitions : - Mean, Mode, Median, Standard Deviation - Coefficient of Variation (CV) is the ratio of the SD to the average. It is a measure of relative precision expressed as percentage • Reference ranges : As per IFCC recommendations, reference values are based on that of a reference individual, it is established in healthy individuals based on application of statistical methods to values generated in the lab 67
  68. 68. Reference ranges • What do I do when controls are out of established reference ranges? – Results of the normal donor control are expected to be within the established reference range. If results exceed reference range limits, follow corrective action: • Repeat test using same aliquot • If the results still exceed the limits, do not automatically invalidate patient results – Due to the 95% confidence interval, 1 in 20 specimens from healthy individuals drawn at random can be outside reference range limits due to biological factors 68
  69. 69. Control Materials • Specimens that are analyzed for QC purpose are known as control materials • Control materials should be available : -in a stable form -in aliquots or vials -for analysis over an extended period of time, at least 1 yr • Minimal vial-to-vial variation should exist • Should have preferably the same matrix as the specimen 69
  70. 70. Types of Control Materials • Assayed – mean calculated by the manufacturer – must verify in the laboratory • Unassayed – less expensive – must perform data analysis • “Homemade” or “In-house” – pooled sera collected in the laboratory – characterized – preserved in small quantities for daily use 70
  71. 71. Managing Control Materials • Sufficient material from same lot number or serum pool for one year’s testing • May be frozen, freeze-dried, or chemically preserved according to instructions by the manufacturer • Requires very accurate reconstitution if this step is necessary • Always store as recommended by manufacturer 71
  72. 72. Calibrators • Has a known concentration of the substance (analyte) being measured • Used to adjust instrument, kit, test system in order to standardize the assay • Sometimes called a standard, although usually not a true standard • This is not a control 72
  73. 73. Control Charts • A common method to compare the values observed for control materials with their known values is the use of control charts • Simple graphical displays in which the observed values are plotted versus the time when the observations are made • Known values are represented by an acceptable range of values • When plotted points falls within the control limit- method is performing properly • When points falls outside control limit – problem may be developing 73
  74. 74. LEVY- JENNINGS GRAPH L-Js are the process control graphs wherein the daily Q.C. values for all levels of controls are plotted (minimum 20 values) and an inference about the run is drawn , to decide “in control” or “out of control run.” Advantage: •Simple data analysis and display •Easy adaptation and integration into existing control practices •A low level of false rejection or false alarms •An improved capability for detecting systematic and random errors 74
  75. 75. LEVEY - JENNINGS GRAPH • It should be automatically generated for the parameters chosen in a QC template • Should be available for viewing by day, month, and other fractions of the year • Use limit criteria either calculated from the data, or from user defined means and SDs • Use red for data points that are outliers 75
  76. 76. LJ CHART PLOTTED : AN EXAMPLE 76
  77. 77. Westgard Rules (Generally used where 2 levels of control material are analyzed per run) • 12S rule • 13S rule • 22S rule • R4S rule • 41S rule • 10X rule 77
  78. 78. Westgard – 12S Rule • Warning rule • One of two control results falls outside ±2SD • Alerts tech to possible problems • Not cause for rejecting a run • Must then evaluate the 13S rule 78
  79. 79. 12S Rule = A warning to trigger careful inspection of the control data 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Mean Day +1SD +2SD +3SD -1SD -2SD -3SD 12S rule violation 79
  80. 80. Westgard – 13S Rule • If either of the two control results falls outside of ±3SD, rule is violated • Primarily sensitive to random error • Run must be rejected • If 13S not violated, check 22S 80
  81. 81. 13S Rule = Reject the run when a single control measurement exceeds the +3SD or -3SD control limit 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Mean Day +1SD +2SD +3SD -1SD -2SD -3SD 13S rule violation 81
  82. 82. Westgard – 22S Rule • 2 consecutive control values for the same level fall outside of ±2SD in the same direction • Sensitive to systematic error • Patient results cannot be reported • Requires corrective action 82
  83. 83. 22S Rule = Reject the run when 2 consecutive control measurements exceed the same +2SD or -2SD control limit 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Mean Day +1SD +2SD +3SD -1SD -2SD -3SD 22S rule violation 83
  84. 84. Westgard – R4S Rule • One control exceeds the mean by –2SD, and the other control exceeds the mean by +2SD • The range between the two results will therefore exceed 4 SD • Random error has occurred, test run must be rejected 84
  85. 85. R4S Rule = Reject the run when 1 control measurement exceed the +2SD and the other exceeds the -2SD control limit 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Mean Day +1SD +2SD +3SD -1SD -2SD -3SD R4S rule violation 85
  86. 86. Westgard – 41S Rule • Requires control data from previous runs • Four consecutive QC results for one level of control are outside ±1SD • Sensitive to systematic error 86
  87. 87. Westgard – 10X Rule • Requires control data from previous runs • Ten consecutive QC results for one level of control are on one side of the mean (above or below, with no other requirement on the size of deviation) • Sensitive to systematic error 87
  88. 88. 10x Rule = Reject the run when 10 consecutive control measurements fall on one side of the mean 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Mean Day +1SD +2SD +3SD -1SD -2SD -3SD 10x rule violation 88
  89. 89. External Quality Assessment • All the control procedures described previously have focused on monitoring of a single lab • These procedures constitute internal QC, to distinguish them from procedures used to compare the performance of different laboratories are known as external Quality assessment • These two procedures are complimentary • Internal QC- daily monitoring of precision & accuracy • External QA- long term accuracy of analytical methods 89
  90. 90. • EQA results evaluate performance of the laboratory against other laboratories participating in the same program • Different programs do this in different ways. Eg, t-test is used to test the statistical significance of any difference b/n an individual lab’s observed mean & the group mean • When the diff. is significant lab. is alerted • Results are instrument and protocol specific • EQA results should be formally documented within the lab and should be available on request External Quality Assessment 90
  91. 91. • In India EQA is done by Govt. / private organizations - National Accreditation Board for Testing & Calibration Laboratories (NABL) , Dept. of Science & Technology,GOI.(http://www.nabl-india.org) - ACBI-CMC External Quality Assurance Scheme, Christian Medical College, Dept. of Clinical Biochemistry, Chennai(http://www.cmcvellore.ac.in) External Quality Assessment in India 91
  92. 92. Proficiency testing • Laboratories should all enroll and satisfactorily participate in a performance evaluation/assessment program – If conventional proficiency testing is not available, the laboratory must exercise an alternative performance assessment system for determining the reliability of analytic testing (sample splitting for inter-laboratory testing) – If the lab has more than one method-system for performing tests for an analyte, it must be checked against each other at least twice a year for correlation of patient results 92
  93. 93. New Quality Initiatives • Several new quality initiatives have been developed & implemented to ensure that labs incorporate the principles of Quality Management & QA in daily operation - Six Sigma process - Lean Production - ISO 9000 - Joint Committee for Traceability in Laboratory Medicine (JCTLM) Guidelines. 93
  94. 94. 94 To ensure that a laboratory practices and provides quality assurance for all phases of testing, the laboratory should:  Enroll and satisfactorily participate in a performance evaluation/assessment program  Establish reference ranges for analytes being tested  Document training and competency assessment for their technicians  Provide review and verification of all results released, including verbal result reports → SUMMARY
  95. 95. SUMMARY • Quality control is a part of a total laboratory control program under Total Quality Management • TQM is responsible for organizational development and management for improved quality in all aspects • Five Qs- Qlp,QC,QA,QI,QP constitute the TQM framework • Quality Control is achieved through proper documented and validated interventions at Preanalytical, analytical and post analytical stages • Quality Assurance is internal Quality assessment plus external Quality assessment X 95
  96. 96.  No matter how good the quality system is on paper, quality cannot be achieved if the theory cannot be translated into practice Quality costs, but poor quality costs more … 96
  97. 97. References • Teitz Fundamentals of Clinical Chemistry,6th Ed. • Harold Varley 4th Ed. • Bailey & Scott’s 12th Ed. • Internet 97
  98. 98. Thank You 98

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